GDUFA IV: Groups urge FDA to take steps to boost confidence in generic drugs
Consumer health groups urged the US Food and Drug Administration (FDA) to allocate more resources for testing generic drugs and to implement stricter metrics for postmarket safety reporting at a public meeting on Thursday discussing the reauthorization of the Generic Drug User Fee Amendments (GDUFA IV).
They emphasized the importance of transparent communication with the public and effective postmarket surveillance in rebuilding trust in the safety and therapeutic equivalence of generic medicines.
The current GDUFA III program is set to expire on 30 September 2027. Congress must reauthorize the generic drug review program prevent it from expiring.
FDA will review public comments from the meeting, make revisions, and submit the GDUFA IV recommendations and commitment letter to Congress as part of the process to reauthorize the agreement. Comments must be submitted to the docket by 17 October 2026.
Stronger postmarketing controls
Several speakers expressed that FDA should receive additional resources to test generic drugs and to enhance postmarketing safety reporting. Such measures would help restore public confidence the safety and quality of generic drugs, a trust that has declined in recent years, according to Diana Zuckerman, the president of the National Center for Health Research.
“We appreciate that GDUFA has reduced the backlog of generic drug applications. Everyone agrees that this is very important and a wonderful accomplishment. But I personally, and our center, has growing concerns that FDA has won this important battle, but we are losing the war [of] public trust. ... Everyone used to assume that generic drugs were equivalent to brand name drugs and not everyone assumes that anymore.”
Zuckerman credited some of that loss of trust to the findings of a series of investigations conducted by ProPublica that raised questions about FDA’s oversight of generic drugs. In a June 2025 report, ProPublica detailed how the FDA permitted substandard drugs that had failed inspections overseas to enter the country, despite being banned from import.
In another example, she referred to a case from 2024 involving Synapse Labs, a testing lab in India, which generated false bioequivalence data that had been referenced in approved and tentative abbreviated new drug applications (ANDAs).
Zuckerman noted that once the issues were identified, the FDA issued a General Correspondence Letter (GCL) to Synapse in February 2024, drawing attention to significant data integrity concerns associated with these studies. Additionally, the agency revised the bioequivalence ratings for 400 drugs tested by Synapse. Yet these drugs remained available on the market for over a year, and patients were not informed.
“This decision was very dangerous to patients but it was also unfair to the generic companies whose safe and effective medicines were competing with those 400 drugs, and it is unfair to all generic drug companies that make excellent medications when patients do not know which generics are better or safe and which ones are not,” she said.
Zuckerman added that “FDA needs to follow through on banning unsafe drugs even if this results in shortages. It is better to have a shortage than to have unsafe drugs on the market.”
Suzanne Robotti, founder and president of the MedShadow Foundation, stated that for the past two years, her organization has been examining the quality of generic drugs available in the marketplace. “Our findings indicate that after approval, generic drugs can perform differently compared to their brand-name counterparts.”
Robotti said that “the proposed GDUFA IV agreement contains extraordinarily detailed performance goals for the FDA. Deadlines for reviews, inspections, meetings. Where are the comparable performance goals for assuring the quality of generic drugs after approvals?”
“GDUFA should shift its focus from speedy approvals to stronger oversight of postmarketing safety,” she added.
She stated that the FDA should be able to utilize technologies like the Fast Assessment of Solutions, Therapeutics, Pharmaceuticals, and Supplies (FASTPASS), which was developed by the NIH Advanced Research Projects Agency for Health (ARPA), to test generic medicines and safeguard Americans from substandard or contaminated medications. FASTPASS allows for rapid sampling of pharmaceutical shipments that can verify drug quality at ports and distribution centers.
Failed inspections
A suggestion was made during the meeting for GDUFA IV to include a provision requiring the FDA to notify the public when a company fails an inspection.
Michael Abrams, a senior researcher at Public Citizen said that “the generic commitments letter should promise to create a reporting structure that informs the public when manufacturers fail inspections. This system must be timely and name the specific drugs so that prescribers and consumers stay current on manufacturing problems related to their indications.”
Zuckerman concurred with this recommendation. “The GDUFA commitment letter should include an FDA-based reporting structure that informs the public when manufacturers fail inspections. If ProPublica can do it, surely FDA can do it, and do it even better because they have access to information no private entity would ever have.”
